DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert ...

This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods. About a decade ago, FDA and other regulatory agencies introduced a series of ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies ...

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts. Analytical quality ...

Advancing analytical techniques is all well and good, but unless those advances in technology are accompanied by matching strides in technique management, the true potential of better methods may not ...

Dublin, Nov. 18, 2022 (GLOBE NEWSWIRE) -- The "Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered" training has been added to ResearchAndMarkets.com's ...